| CTRI Number |
CTRI/2024/05/067121 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound versus expired carbondioxide in early recognition of successful intubation |
|
Scientific Title of Study
|
Comparison of ultrasound and end tidal carbon
Dioxide monitoring in early recognition
Successful endotracheal intubation a
Prospective observational study
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ganeshamoorthy B |
| Designation |
Postgraduate |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology sri ramachandra institute of higher
education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9092129443 |
| Fax |
|
| Email |
drganeshamoorthybaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soma Ganesh Raja |
| Designation |
Associate Professor |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology sri ramachandra institute of higher
education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9894162665 |
| Fax |
|
| Email |
drsoms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soma Ganesh Raja |
| Designation |
Associate Professor |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology sri ramachandra institute of higher
education and research, Ramachandra Nagar, Porur
TAMIL NADU
600116
India |
| Phone |
9894162665 |
| Fax |
|
| Email |
drsoms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Dr Ganeshamoorthy B |
| Address |
A6, Department of Anaesthesiology and Pain Medicine Sri
Ramachandra institute of higher education and research, Porur ,
Chennai 600116 |
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ganeshamoorthy B |
Sri Ramachandra institute of higher education and research |
Room no A6, 6th floor ,
Department of
Anaesthesiology and
Pain Medicine Sri
Ramachandra institute
of higher education and
research, Porur
Chennai
TAMIL NADU |
9092129443
drganeshamoorthybaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra institute of higher education and research, Porur, Chennai 600116 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Requiring elective surgery under general Anesthesia |
|
| ExclusionCriteria |
| Details |
Expected difficult laryngoscopy
Indications to Awake fiberoptic intubation
Parturient
Patient refusal
Inability to give consent to the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine validity of ultrasound and end tidal carbon dioxide monitoring in
early recognition of successful endotracheal intubation |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2024 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endotracheal intubation is an important step in providing general anesthesia. Confirmation of successful endotracheal intubation is usally done by chest auscultation and capnography waveform by end tidal carbondioxide. Early recognition has to be made for any unintentional placement of endotracheal tube in oesophagus to avoid complication. With the advent of ultrasound, it has recently been used to confirm endotracheal intubation with real time images |